1. Field of the Invention
The invention relates to devices and methods for treating female sexual dysfunction, and more particularly, to such devices and methods that promote blood flow to the genital region, specifically the clitoris of a female patient.
2. Description of Related Art
The clitoris in the human female consists of a cylindrical, erectile organ composed of three parts: the outermost glans or head, the middle corpus or body, and the innermost crura. The glans of the clitoris is visualized as it emerges from the labia minora, which bifurcates to form the upper prepuce anteriorly and the lower frenulum posteriorly. The body of the clitoris consists of two paired corpora cavernosa of about 2.5 cm in length. The body extends under the skin at the corona to the crura. The two crura of the clitoris, formed from the separation of the most proximal portions of the corpora in the perineum, attach bilaterally to the undersurface of the symphysis pubis at the ischiopubic rami.
A fibrous tunica albuginea ensheathes each corporal body made up of lacunar space sinusoids surrounded by trabecula of the vascular smooth muscle and collagen connective tissue. No retractor clitoridis muscle exists in humans as it does in other animals such as cattle and sheep, however a supporting suspensory ligament does hold the clitoris in the introital region.
The main arterial supply to the clitoris is from the ilio-hypogastric-pudendal arterial bed. The internal pudendal artery is the last anterior branch off the internal iliac artery. Distally, the internal pudendal artery traverses Alcock""s canal, then terminates as it supplies the inferior rectal and perineal artery which supply the labia. The common clitoral artery continues to the clitoris. This artery bifurcates into a dorsal clitoral artery and a cavernosal clitoral artery.
In the normal female, autonomic efferent innervation of the clitoris passes from the: pelvic and hypogastric nerves to the clitoris. Pelvic nerve stimulation results in clitoral smooth muscle relaxation and arterial smooth muscle dilation. This relaxation and dilation result in an increase in clitoral cavernosal artery inflow and an increase in clitoral intracavernous pressure, which lead to tumescence and extrusion of the glans clitoris.
Clitoral erectile insufficiency or reduced clitoral arterial flow may be caused by atherosclerosis, diabetes, or age-related causes, among other factors. Reduced clitoral arterial flow may lead to fibrosis of the clitoral cavernosa and reduced clitoral physiological function. In an animal model, Park et al. demonstrated that significant collagen build up occurs when the arterial inflow to the clitoris is compromised. This work demonstrated the importance of maintaining arterial flow to the clitoris to prevent collagen build up and fibrosis on the smooth muscle. See Park, K., et al., Vasculogenic Female Sexual Dysfunction: The Hemodynamic Basis for Vaginal Engorgement Insufficiency and Clitoral Erectile Insufficiency, IJIR, 9:27-37, 1997.
It is believed that the difficulty or inability to achieve clitoral tumescence may be related to and associated with other symptoms of female sexual arousal disorder. According to the International Consensus Report on Female Sexual Dysfunction, Female Sexual Arousal Disorder (FSAD) is defined as the persistent or recurrent inability to attain or maintain adequate genital lubrication or swelling responses resulting in personal distress. FSAD may be expressed as a lack of subjective excitement or lack of genital (lubrication/swelling) or other somatic responses (AFUD Consensus Report of FSD, 1998).
U.S. Pat. No. 5,693,002 to Tucker and U.S. Pat. No. 5,725,473 to Taylor both disclose devices for applying suction to the female clitoris. However, the devices disclosed in these patents are of a generally rudimentary and crude nature and are not suitable for e.g. clinical use. The disclosed devices provide no regulation of vacuum level, no correlation of vacuum level with degree of sexual arousal, as measured by blood-flow readings or other data, no mechanism for conveniently and easily breaking the suction once it is applied, no mechanism to modulate vacuum pressure and thereby refresh arterial blood flow, and, indeed, no mechanism of any kind for data gathering.
Other devices are known for applying suction to the male penis. One such system, known as the TOUCH II Vacuum Erection System (Mentor Urology), generates a vacuum in a cylinder disposed over the penis. After the penis is inserted into the cylinder, a pump activation button is pressed for approximately 3 seconds, facilitating and encouraging blood flow into the penis. After approximately 10 seconds of such blood flow, the pump is activated again for about 1-2 seconds. The process is repeated until a full erection is achieved. A constriction ring placed at the base of the penis impedes venous blood flow, trapping blood in the penis and allowing the erection to be maintained for intercourse. Other typical erection-aiding vacuum devices are disclosed in U.S. Pat. Nos. 5,462,514 and 5,243,968. The size, shape, suction level and/or other factors associated with such male-directed devices generally have made them unsuitable for use with the female anatomy, however. Other typically unsuitable devices are shown in e.g. U.S. Pat. Nos. 4,111,192 and 5,336,158.
A non-pharmacological approach to treatment that causes blood flow and engorgement, thereby applying a stimulus to the sensory nerve endings in the clitoris, would be very beneficial to a large group of women complaining of FSAD.
Therapeutic devices and methods according to embodiments of the invention encourage or cause clitoral engorgement to assist in the treatment of female sexual dysfunction. A vacuum is created over the clitoris, or suction is applied to the clitoris, to create a negative pressure in the clitoris that is lower than the systolic blood pressure. This tends to promote engorgement of the clitoris with blood.
More specifically, a clitoral therapy device according to an aspect of the invention includes a suction applicator, the suction applicator being constructed for placement in association with the clitoral region of a female patient, a suction source in fluid communication with the suction applicator to create suction pressure in the suction applicator, and a signal-handling device, operably coupled with at least the suction source, for handling electrical signals related to the suction pressure. The signal-handling device can be constructed to regulate the suction pressure drawn in the suction applicator, and can include a microprocessor that compares suction pressure to a variable associated with sexual arousal of the patient.
The electrical signals can include data signals, and the signal-handling device can be constructed to download the data signals to a remote location. The signal-handling device can include an on/off switch. A display, operably coupled with the suction applicator, displays a variable related to the suction pressure in the suction applicator. At least one sensor senses suction pressure in the suction applicator.
According to another aspect of the invention, a system for applying suction to the clitoral region of a female patient includes means for application to the clitoral region of the patient, means, operably coupled to the means for application, for creating a suction force at the means for application, and means for electrically powering the means for creating a suction force. The system also can include means, operably coupled to at least one of the means for application and the means for creating a suction force, for generating data related to the suction force. The system also can include means for processing the data.
The means for generating data can include at least one sensor, and the system can include means for regulating the means for creating a suction force, the means for regulating correlating suction force to a desired variable. The desired variable can be a blood-flow variable. The desired variable also can be related to sexual arousal of the patient. The system can include a memory for storing data related to operation of the system.
According to another aspect of the invention, a method of encouraging engorgement of the clitoris of a female patient includes applying a suction force to the clitoris or clitoral region of the patient, reducing intra-clitoral pressure to a level below the systolic blood pressure of the patient to encourage engorgement of the clitoris, and quantifying at least one variable, the at least one variable being chosen from the group comprising suction force and patient blood flow. The quantified variable can be displayed on a display device, and the method can include electrically powering a suction device to apply the suction force. The method also can include automatically correlating suction force to a patient variable, and the suction force can create a vacuum over the clitoris of the patient.
According to another aspect of the invention, a clitoral therapy device includes a housing, a vacuum cup in fluid communication with the housing, the vacuum cup having an opening constructed for placement over the clitoris of a female patient, an airflow device in fluid communication with the vacuum cup, the airflow device increasing suction pressure in the vacuum cup to draw blood into the female clitoris, and a modulator, operably coupled with the vacuum cup, to vary the suction pressure in the vacuum cup and promote recycling of arterial blood in the clitoris. The airflow device can include a motor.
The vacuum cup opening can be a first opening, and the modulator can include a second opening operably coupled with the vacuum cup. The second opening can be disposed in a wall of the vacuum cup for manual covering and uncovering with a human finger. A connection member connects the vacuum cup to the housing, according to this embodiment, and the second opening is disposed in the connection member. The connection member can be a generally tubular member. The second opening can be disposed in a wall of the housing. A penis-shaped motor housing can be provided, within which at least a portion of the suction source is disposed.
According to another aspect of the invention, a housing is combined with a vacuum cup, the housing being in the shape of at least a portion of a male penis, the vacuum cup being in fluid communication with the housing, and the vacuum cup having an opening constructed for placement over the clitoris of a female patient. An airflow device is in fluid communication with the vacuum cup, the airflow device increasing suction pressure in the vacuum cup to draw blood into the female clitoris.
According to another aspect of the invention, a motor cover is in the shape of at least a portion of a male penis, and a motor is disposed within the motor cover. A battery compartment is disposed within the motor cover to receive and accommodate at least one battery. A vacuum cup is in fluid communication with the motor, the motor comprising a vacuum pump for drawing a vacuum in the vacuum cup. The vacuum cup has an opening constructed for placement over the female clitoris.
According to another aspect of the invention, a method of applying suction to the clitoral region of a female patient includes providing a suction applicator constructed for close association with the clitoral region of a female patient, placing the suction applicator in fluid communication with a suction source to create suction pressure in the suction applicator, placing the suction applicator in close association with the clitoral region of a female patient, and activating the suction source to create the suction pressure.
The device further can include means, connected to the suction applicator or the suction source, for applying a topical medication to the skin of the patient in the proximity of the suction applicator. The means for applying can include a reservoir at the suction applicator or remote from the suction applicator.
A suction applicator according to an embodiment of the invention includes a soft portion constructed to contact the patient""s skin and a rigid portion constructed to support the soft portion. The soft portion constructed to contact the patient""s skin can include a concave shape and a convex shape immediately adjacent to the convex shape. The suction applicator also can be constructed to completely cover the vaginal labia of a female patient.
A suction-pressure varying device according to an embodiment of the invention, operably coupled with the vacuum cup, can adjust suction pressure at a more gradual rate than the modulator. The suction-pressure varying device can include a wheel in association with the housing.
Other aspects of the invention will be apparent from the remainder of this application.